EMBRACE EVERY POSSIBILITY FIRST BLUE LASER IN THE WORLD For Both Surgery and Therapy

FIRST BLUE LASER IN THE WORLD WITH 3 WAVELENGTHS FOR SURGERY AND THERAPY

K-Laser Blue Derma is a three-wavelength device that mainly exploits the 445 nm one. Unlike all other infra-red lasers, K-Laser is not based on water absorption but rather on the absorption of melanin and haemoglobin. This feature allows obtaining many advantages in the surgical field. Thanks to its higher energy coefficient, compared to infra-red laser, it has increased antiseptic and biostimulating properties. The 445 nm wavelength is combined with 660 nm and 970 nm ones since they support superficial and deep tissue biostimulation.

ADVANTAGES: no maintenance, low cost of consumption material and maximum safety. All surgical components can be sterilised.

K-Laser Blue Derma: 445 nm - 660 nm - 970 nm Absorption coefficient Absorption 445 660 970

The 445nm wavelength interacts with the molecules at systemic level and is absorbed by both haemoglobin and melanin much better than with an infra-red laser. The blue wavelength is also effective on numerous bacterial strains, 445 nm thus exploiting its antiseptic properties and achieving excellent results in tissues incision, both for surgical and vascular purposes. It is also useful in treating diabetic ulcers and bedsores.

The 660nm wavelength can transfer an optimal dosage of energy to the tissue. This energy is thus stored at cellular 660 nm level with subsequent increase in both bacterial proliferation and metabolism. Thus, it allows obtaining remarkable results in the healing of wounds,diabetic and vascular ulcers.

The 970nm wavelength is absorbed by the water contained in our body: most of such energy is turned into heat. The 970 nm deep layers of tissues thus become localised heat points able to generate temperature gradients at cellular level and to stimulate the local microcirculation thanks to the oxygen supply provided by this wavelength.

2 EFFECTIVE in both Surgery and Therapy

In the Therapeutic filed,K-Laser Blue Derma uses several pulse frequencies through dynamic stages in order to produce a combination of: analgesia, reduction in , biostimu- lation and antisepsis. In surgery, the three wavelengths can be combined, thus increasing the effectiveness of surgical incisions as well as haemostatic, biostimulating and antiseptic effects.

Pain management therapy Biostimulation Dermatological surgery Inflammation reduction Reinforced immune system Melanic spots Deep biostimulation Wound healing Photorejuvenation Increase in the metabolic and vascular Ulcers / Diabetic foot Bacteria reduction activity Bedsores Superficial biostimulation Reinforced immune system Wound healing Cellular oxygen Reinforced immune system Vitamin D Vascular surgery Lesion detector Haemostasis Ulcers / Diabetic foot Bedsores 970 nm

660 nm

445 nm

445 nm

3 K-LASER BLUE DERMA Advanced Technology

K-Laser Blue Derma intuitive software is quick and accurate and easily guides the physician in all the treatments available. The parameters that determine each stage of the treatment, such as wavelength, energy, time, power and frequency, are automatically managed in an accurate and meticulous way, despite leaving the operator free to easily create new personalised protocols.

Interchangeable handpieces in special metal all sterilizable

Quick and intuitive software Multiuse, sterilizable Tips and fibres

K-Laser on demand Rechargeable battery

4 K-LASER BLUE DERMA New source of energy

Within the electromagnetic spectrum and among the non-ionising radiations, the blue wavelength is the most powerful in terms of energy: this translates into several benefits for the treated tissues.

THE ELECTROMAGNETIC SPECTRUM

HIGH ENERGY WAVE- LENGHT

GAMMA RAYS

1 NM IONIZING X-RAYS RADIATION

ULTRAVIOLET RAYS

K-LASER BLUE 100 NM 445 nm VISIBILE 660 nm 970 nm LLLT 380-700 NM Nd:YAG Er:YAG INFRARED RAYS

Co2 10.000 NM

NON-IONIZING MICROWAVES RADIATION

10 CM

RADIO WAVES

LOW ENERGY

5 FIELDS OF APPLICATION Surgery

K-Laser Blue Derma is characterised by an interface that allows choosing from several treatments, thus ensuring unprecedented accuracy of incisions in the surgical field. The “Blue” 445 nm wavelength can also be combined with the infra-red 970 nm one, thus making for a better ablative effect (DISB) or increased biostimulating properties (ISB). These two modalities are K-Laser patents and make for a unique and exclusive surgical performance.

Vascular Surgery

Teleangectasias Legs teleangectasias Nose varicose veins Dermathological Surgery Ruby angioma Light Spider angioma Black benign nevus Flat angioma Cavernous small angioma Endovascular Papilloma Condiloma Pendulous broma Biopsy

Contact Surgery

Podiatry

Onychomycosis Age/solar spots Ingrown

Dermathological Treatments

Photorejuvenation Stretch marks Scars Resurfacing 6 FIELDS OF APPLICATION Therapy

K-Laser Blue Derma intuitive software operates following more dynamic stages. Therefore, it allows modulating the parameters of the selected program, such as wavelength, frequency, energy and power. Using only one device, this feature guarantees a wide range of highly efficient medical applications, through tissue repair and a reinforced immune system.

Pain Therapy

Chronic pain Severe pain In ammation Dermatological Therapy Oedema and in ammation Vulgaris Wounds healing Diabetic

Therapy of the Tissues

Mucositis Dermatitis Reinforced immune response Bone matrix stimulation Lesion detector 7 K-LASER BLUE DERMA Excellence and maximum Performance in Surgery

K-Laser Blue Derma, compared to surgical devices that use infra-red wavelengths, uses the blue light, thus ensuring high-level surgical performance, thanks to the reduction of thermal damage and to its peculiar interaction with haemoglobin. Thanks to these features, it guarantees increased cutting effectiveness, much higher than the one obtained with infra-red lasers, and the complete absence of water absorption help drastically reduce the overheating of the surrounding tissues.

K-Laser Blue Derma guarantees ideal visibility of the operative area thanks to immediate haemostasis. In contact surgery, the use of special sterilisable fibres prevent possible cross- infections while guaranteeing a clean and bloodless operative area.

Infrared Laser

8 K-LASER BLUE DERMA Clinical studies

K-Laser Blue Derma can be used effectively to treat skin injuries and imperfections thanks to its high technology that consists of several interchangeable hand-pieces and thanks to its dynamic software that allows choosing from numerous application fields. Clinical results are the basis of the effectiveness of K-Laser treatments in Surgery:

Dermatological Surgery

Light nevus Papilloma

Before After Before After

Light nevus Seborrheic keratosis

Before After Before After

Tuberous nevus Fibroma pendulum

Before After Before After 9 K-LASER BLUE DERMA Clinical studies

Vascular Surgery Angioma Nose Telangiectasias

Before After Before After

Telangiectasias Telangiectasias

Before After Before After

Rosacea Telangiectasias

Before After Before After

10 K-LASER BLUE DERMA Clinical studies

Dark Spot Dermatological Treatments Solar-age spots Acne Vulgaris

Before After Before After

Solar-age spots Acne Vulgaris

Before After Before After

Solar-age spots Photorejuvenation

Before After Before After

11 K-LASER BLUE DERMA K-Laser Dynamic Therapy

Effects on metabolic processes

Oedema and inflammation The laser acts on inflammation mediators, such as macrophages, neutrophils and lymphocytes, thus accelerating the healing of inflammatory processes.

Angiogenesis and neovascularity The laser increases tissues oxygenation, thus accelerating healing processes.

Nerve regeneration The proliferation of growth factors mediated by laser therapy promotes nerve regeneration as well as the formation of myelin, which are fundamental healing processes. Cartilage production The laser increases the production of chondrocytes and collagen, thus making for higher deposition of cartilage and improving articular function.

Collagen production Optimal alignment and remodelling of collagen fibres reduces the formation of and increases tissues elasticity.

Muscle regeneration The laser repairs damaged muscle fibres Bone neoapposition and activates satellite and myogenic cells, The laser promotes the proliferation of thus promoting the regeneration of muscle osteocytes as well as the reshaping of the tissue. extracellular bone matrix, thus accelerating 12 tissue repair. Effectiveness and benefits for Pain Therapy

K-Laser Dynamic Therapy is an excellent multidisciplinary therapy

K-Laser Dynamic therapy uses several pulse frequencies to produce a combination of analgesia, inflammation reduction, biostimulation and antimicrobial effect, thus accelerating the regeneration of tissues and increasing the energy available to cells. Cells can thus absorb nutrients more quickly as well as eliminate waste substances. As a result of the exposition to laser light, the cells that constitute tendons, ligaments and muscles are repaired more quickly. K-Laser Dynamic Therapy has antiedemics effects because it produces vasodilation and because it activates the lymphatic drainage system: this results in swelling reduction.

13 K-LASER BLUE DERMA Clinical studies in Pain Therapy

Optimum effectiveness in: Physiotherapy, Rehabilitation, Traumatology and Post-Surgery Therapy

K-Laser experience acquired in analgesic therapy relates to several both severe and chronic inflammatory and pain conditions. The painful conditions that are mainly treated are the ones involving the cervical and lumbar spine, the one of the shoulder, the elbow, the wrist, the hand, the hip, the knee and the foot. In Traumatology and Rehabilitation, it is used to treat the tibio-tarsus sprain, muscle contusion and tears, tendinitis and inflammation of ligaments.

Anti-inflammatory effect Hallux valgus K-Laser therapy has a beneficial effect on pain receptors since it increases their threshold and releases endorphins. Pain is also reduced thanks to the anti-inflammatory and anti- oedema effect.

An example of this is the treatment of hallux valgus, where pain and inflammation are managed effectively

Oedema and congestion Bilateral tendinitis of the Achilles tendon K-Laser therapy has an anti-oedema effect because it reduces vasodilation and because it activates the lymphatic drainage system (draining the oedematous areas). Thus, swelling caused by traumas and/or inflammation is reduced.

Before After 2 days 14 K-LASER BLUE DERMA Clinical studies in Dermatological Therapy

K-laser therapy significantly increases the formation of new capillaries, thus accelerating the healing process of damaged tissues, healing wounds and reducing the damaged area. In addition, benefits include angiogenesis increase, which causes vessels to dilate temporarily with the augmentation of the blood vessels diameter. The increased supply of blood in the damaged area facilitates healing and reduces pain.

Heel bedsore Wound healing

Effects linked to the inhibition of bacterial proliferation and to increased cellular growth that allows achieving excellent results in terms of healing of wounds, ulcers and bedsores.

Before After 15 days

Bedsore in the sacral area

After 1 month After 2 month

Before After 2 days An example of this is the bedsore in the sacral area for which K-Laser therapy is used to biostimulate the tissues.

After 4 days After 6 days 15 K-LASER BLUE DERMA Clinical studies in Dermatological Therapy

Diabetic foot K-Laser therapy increases the production of specific enzymes for the transport of oxygen, thus facilitating the repair and the regeneration of damaged tissues.

Ulcers Diabetic ulcer affects cutaneous and subcutaneous tissues and is not likely to heal spontaneously. Diabetic ulcers affecting the foot are not easy to treat and often need invasive and painful treatments as well as careful assessment in terms of angiology and hystopathology. K-Laser therapy can be very useful thanks to its ability to act on tissue biostimulation, thus favouring the healing process of damaged tissues.

Ulcerated wounds in diabetic patients

Ulcerated amputation stump ulcer is localised at apical level Neuropathic ulcer

Before After Before After

Neuropathic ulcer Ulcerated wound localised on the fifth metatarsal head caused by a sensory neuropathy.

Before After 1 weeks After 3 weeks

16 K-LASER BLUE DERMA Clinical studies in Dermatological Therapy

In dermatological therapy excellent results are obtained for the following conditions: onychomychosis, hell spines, tendinitis, plantar fascitis and metatarsalgia.

Onychomychosis Nail K-Laser therapy initially guarantees a reduction of the inflammation and, afterwards, the eradication of the fungus infection with complete disinfection of the treated area.

Before After 2 months

Before After 15 days After 4 months After 6 months

17 Effectiveness of the reinforced immune-mediated response

K-Laser therapy increases the immune-mediated response in case of disease processes. Through a series of biochemical and cellular processes, this allows the organism to properly defend itself.

Several analysis carried out at the ICGEB (International Centre for Genetic Engineering and Biotechnology, Trieste, Italy), have proved that this therapy can reinforce the immune- mediate response and can promote vascular normalisation [Ottaviani et al. Laser Therapy Inhibits Tumor Growth in Mice by Promoting Immune Surveillance and Vessel Normalization. EBioMedicine. 2016 Jul 25. pii: S2352-3964(16)30340-1. doi: 10.1016/j.ebiom.2016.07.028].

18 Tissue injuries

Oral mucositis Onco-haematologic paediatric patient treated with chemotherapy. The patient Before presents ulcers and on the lips and inside the cheeks. Treated with 4 sessions of K-Laser After 4 days therapy.

After 11 days

Dermatitis Scleroatrophic lichen

Oncology patient with breast cancer who Patient with chronic recurrent was treated with radiotherapy. with wounds in the breasts area. The patient presents severe dermatitis in the After 9 sessions of K-Laser therapy the inframammary crease. patient’s symptoms and marks have Treated with 6 sessions of K-Laser therapy. significantly improved.

Osteosynthesis Actinic keratoses

The K-Laser therapy used helped accelerate Patient with actinic keratoses treated with the healing process and restored the func- K-Laser therapy who presents significant tionality of hands affected by metacarpus skin improvements. fractures, without side effects.

19 K-LASER BLUE DERMA Accessories

Revolutionary innovation for advanced surgery and laser therapy

Hand-piece for non contact surgery Art. MP386

Set of non-contact surgical spacers Art. MP387A-MP387B-MP387C-MP387D

Frax hand-piece Art. MP510 (optional)

Endo hand-piece Art. MP399 (optional)

Hand-piece for contact surgery Art. MP384

Optic fibre 200µm Art. 6255678 (optional) Optic fibre 320µm Art. 6255629 Sterilizable

Sterilizable sleeve for contact surgery Art. MP385

Surgical fiber sterilizable Sterilizable tip Optic fiber 320µm Art. MP021HA (optional) Art. MP419 Optic fiber 400µm Art. MP021R (optional) Optic fiber 600µm Ball Tips Art. MP430 (optional) 20 K-LASER BLUE DERMA Accessories

Optic hand-piece for therapy ORL optic for therapy Hand-pieces case holder K-Laser case Art. MP383 Art. MP388 series K-Laser Blue Derma Art. IM017A Art. IM023 (optional)

Wi-FI Pedal Fixed Wi-Fi pedal Protective goggles for the patient Protective glass goggles Portable Art.PF067 Art.62566841 for aesthetic applications for the patient (optional) Art.PF002 Art.6541523 (optional)

Protective goggles for Trolley with carrier for Tips K-Laser Blue Derma trolley High-power led lamp both the operator and Art. PF095 (optional) with smoke extractor Art. PF096 (optional) the patient Art. PF093 (optional) Art.PF002P

21 K-LASER BLUE DERMA

K-Laser has chosen to use semiconductors due to their advantages compared to the other technologies available on the market. This makes K-Laser the brand of the most reliable compact devices in the world.

K-Laser Blue KTP Diode Laser Nd:YAG laser Co2

Wavelength 445 nm + 660 nm 532 nm 810 to 980 nm 1064 nm 10600 nm 970 nm Model type Compact Large Compact Extra large model Extra large model

Maintenance costs Instructions Surgery (soft tissues) Surgery (dermatology) Haemostasis Biopsy Endovascular Vascular face Vascular legs Bacterial infections Photobiomodulation Dark spots Acne active phase Diagnostics Rejuvenation = Suitable = Partially suitable = Non suitable

22 K-LASER BLUE DERMA Technical file

K-Laser Blue Derma has been designed in compliance with directives 93/42/EEC and 2007/47/CE about medical products. According to the norms in force, the device is classified as follows:

Source type Integrated semiconductor laser module

Laser system Class IV (compliant with IEC 60825-1)

Product class Class IIb (compliant with directive 93/42/EEC)

Wavelength 445 nm ± 5nm; 660 nm ± 10 nm; 970 nm ± 15 nm (nm) Overall power (W) 13

Emission Mode CW (continuous emission), pulsed, modality ISB, modality DISB

Protection of liquids Unity: IP20; pedal (non-waterproof cover): IPX5 penetration (Compliant with CEI EN 60601-1) Insulation Class Class II, type B (compliant with CEI EN 60601-1)

Steering beam 660 nm ± 10 nm, max. 1mW

DNRO 12.46 m max

Laser Activation wireless pedal

Power supply Rechargeable battery and external power supply 100 - 240 VAC, 47 - 63 Hz

Display Full color, LCD touchscreen

Handpiece interchangeable sterilisable handpieces in special metal

Fibers 200µm 320µm Multiuse sterilizable

Weight 1300 g (including the handpiece and the rechargeable battery)

23 For further information, visit our website www.klaser.eu or scan this code to discover K-Laser technology K-Laser Blue Derma Engl Rev. 2 K-Laser Blue Derma Engl Rev. even only partial, is strictly forbidden The company may make changes which it deems necessary without any notice. Reproduction,

ELTECH K-LASER S.r.l. Strada Castagnole, 20/H 31100 TREVISO - ITALY Tel. +39 0422 210430 Fax +39 0422 297137 K-LASER and BLUE [email protected] are registered trademarks UNI ISO 9001:2008 ISO 13485 0476 www.klaser.eu by Eltech K-Laser srl UNI ISO 13485:2012 2003 CMDCAS